Imaging Biomarkers Market Size, Share & Trends Analysis Report By Biomarkers (Molecular/Nuclear Biomarkers, Quantitative Imaging Biomarkers), By Imaging Technology, By Application, By End Use, By Region, And Segment Forecasts, 2025 - 2033

Imaging Biomarkers Market Summary

The global imaging biomarkers market size was estimated at USD 13.95 billion in 2024 and is projected to reach USD 39.23 billion by 2033, growing at a CAGR of 12.62% from 2025 to 2033. The growth of the market can be attributed to the increasing burden of chronic diseases such as cancer, neurological disorders, and cardiovascular conditions.

The need for precise, non-invasive diagnostic methods and early disease detection has elevated the clinical relevance of imaging biomarkers. Furthermore, the growing emphasis on precision medicine and patient stratification has reinforced their role in therapeutic decision-making and clinical trial design. Supportive regulatory developments from agencies such as the U.S. FDA and EMA, which are advancing qualification pathways for imaging biomarkers, are enhancing industry confidence. Concurrently, public-private investments in translational imaging research are strengthening discovery, validation, and standardization initiatives across academic and industrial settings.

The current market dynamics emphasize upon an active period of innovation and consolidation. In 2025, Roche was granted FDA approval over its Elecsys PRO-C3 test to measure liver fibrosis and Thermo Fisher Scientific and Roche Diagnostics enlarged their biomarker cancer portfolios with companion diagnostic assays. Such strategic takeovers like the one of Eurofins Scientific to acquire the diagnostic activities of Synlab in Spain show a sense of move towards a networked biomarker services. Thermo Fisher has collaborated with UK Biobank in partnerships with technology developers to undertake massive validation and data integration of biomarkers and bioinformatics.

The market still continues to be redefined by technological advancement. Novel hybrid imaging systems (PET/CT, PET/MRI), novel high-specificity radiotracers, and artificial intelligence and radiomics are allowing quantitative imaging biomarkers (QIBs), which compose objective, reproducible measurements of disease states. Harmonized imaging protocols and cloud-based analytics platforms are enhancing cross-site reproducibility, which is a requirement to qualify regulation and multicenter trials.

The imaging biomarkers industry is growing in recent years due to the essential advances in molecular diagnostics. Cizzle Biotech introduced CIZ1B biomarker assay in March 2025, which is a non-invasive blood test to detect lung cancer at its early stage. This assay can be used to complement imaging-based diagnostic tests like CT and PET scans by identifying high-risk patients, allowing them to be intervened earlier and enhancing their diagnostic processes. The partnership with iGenomeDX will provide scalable accessibility in the U.S., improving its accessibility and supporting the combination of molecular and imaging biomarkers.

In August 2024, Hitachi High-Tech collaborated with Gencurix to create digital technology-based cancer molecular diagnostic tests with biomarker discovery. This project aids personalized medicine by connecting the molecular knowledge to the imaging data to allow the creation of a more specific diagnosis and treatment plan. These two developments point to the trend of combining molecular and imaging biomarkers which is fueling the growth of the market by enhancing diagnostic accuracy, speeding up the process of drug development and by facilitating earlier detection of the disease. All these developments lend strength to the trends toward the use of a more combined biomarker approach, a trend that ongoing future development has put the market squarely on the road to innovation, clinical integration, and a long-term growth trajectory.

As the issue of reimbursement and standardization continues, the integration of imaging with data science and molecular diagnostics is making imaging biomarkers a key component of the diagnostics, drug development, and personalized therapy. Further investment on AI-based quantification as well as approved imaging outcomes will support sustainable market expansion during the forecast period.

Global Imaging Biomarkers Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this report, Grand View Research has segmented the global imaging biomarkers market report based on biomarkers, imaging technology,application, end use, and region.

• Biomarkers Outlook (Revenue, USD Billion, 2021 - 2033)
• Anatomical biomarkers
• Functional biomarkers
• Molecular/Nuclear Biomarkers
• Quantitative Imaging Biomarkers
• Others
• Imaging Technology Outlook (Revenue, USD Billion, 2021 - 2033)
• MRI
• CT
• PET
• SPECT
• Ultrasound
• Others
• Application Outlook (Revenue, USD Billion, 2021 - 2033)
• Diagnostics
• Drug Discovery & Development
• Personalized Medicine
• Disease Risk Assessment
• Others
• End Use Outlook (Revenue, USD Billion, 2021 - 2033)
• Hospitals
• Diagnostic/imaging centers
• Pharmaceutical and Biotech Companies
• Others
• Regional Outlook (Revenue, USD Billion, 2021 - 2033)
• North America
• U.S.
• Canada
• Mexico
• Europe
• UK
• Germany
• France
• Italy
• Spain
• Denmark
• Sweden
• Norway
• Asia Pacific
• Japan
• China
• India
• Australia
• Thailand
• South Korea
• Latin America
• Brazil
• Argentina
• Middle East and Africa (MEA)
• South Africa
• Saudi Arabia
• UAE
• Kuwait

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